New hope for heart failure patients too sick or fragile to undergo
standard open-heart surgery to treat damaged left ventricle

“Our first commercial product, the Revivent™ Myocardial Anchoring
System, represents a new era in heart failure therapy by gently
restoring the function of the left ventricle in these very ill patients.
We are also developing a second generation of Revivent — minimally
invasive, sternal-sparing, with transcatheter delivery on a beating
heart — for patients who have suffered a heart attack but are too
fragile to tolerate invasive heart surgery.”Kenneth Miller,
President and CEO, BioVentrix

SAN RAMON, Calif.--(BUSINESS WIRE)--BioVentrix,
an emerging medical device company, announced today that it has received
CE marking for its Revivent™
Myocardial Anchoring System, which makes possible Less Invasive
Ventricular Enhancement™ (LIVE™), a procedure that restores the left
ventricle from damage done by a heart attack to a more optimal volume
and conical shape, thereby enhancing performance of the heart’s
non-damaged myocardium and improving quality of life.

Prior to Revivent™, reshaping of the left ventricle required an invasive
procedure known as surgical ventricular restoration (SVR), which
required stopping the beating heart and supporting it with
cardiopulmonary bypass, while significant incisions into the heart
muscle are made to excise the scarred, non-functioning (ischemic)
ventricular tissue. The invasive nature of SVR limits the number of
patients for whom the procedure may be performed due to the fragile
nature of this patient population. In contrast, the less invasive
LIVE™ procedure using the Revivent™ system is performed without the need
of cardiopulmonary bypass or making incisions into the heart.

“Heart failure in Europe is more common than most cancers,” said Louis
Labrousse, M.D., professor of Cardiovascular Surgery at Hopital
Haut-Lévêque, Bordeaux-Pessac, France. “Prior to the availability of
Revivent, open-heart surgery could only be applied sparingly among this
very fragile patient population due to its invasiveness. There are some
14 million people in Europe who currently suffer from heart failure.
Unfortunately, this number is expected to more than double by 2020.
Thus, regulatory approval of Revivent is significant news for ischemic
heart failure patients throughout Europe.”

“Because of Revivent, the LIVE procedure can be performed without
cardiopulmonary bypass: therefore the heart is beating and stable, and
there is no major surgical incision in the myocardium,” added Andrews
S. Wechsler, M.D., professor of Cardiothoracic Surgery, Drexel
University College of Medicine, Philadelphia. “Intraoperative monitoring
has documented the excellent hemodynamics present at the end of the LIVE
procedure without vasoactive support. No doubt, regulatory approval of
Revivent will have a significant impact on the treatment of heart
failure patients in Europe going forward.”

“Our innovative Revivent system used during LIVE procedures will empower
cardiac surgery teams not only to ensure optimal clinical outcomes and
enhance quality of life for heart failure patients but also to minimize
risk compared to the previous gold standard of conventional left
ventricle reconstruction surgery,” said Kenneth
Miller, president and chief executive officer of BioVentrix.
“While we are extremely pleased with the regulatory approval of Revivent
in Europe, we are also looking forward to our next-generation Revivent
technology — transcatheter ventricular restoration (TCVR),” added
Miller. “Given the successful clinical outcomes we have achieved with
Revivent, we have fast-forwarded development of our next-gen, endovascular
technology designed to achieve the same results as the LIVE procedure,
but with a sternal-sparing technique. This closed-chest, beating heart,
transcatheter therapy is expected to be a new paradigm for treating
heart failure patients, holding great promise for those who have
suffered a heart attack but are just too sick to tolerate invasive heart
surgery.”

About Revivent™: A Less Invasive Intervention for Heart Failure
Patients

The Revivent™ Myocardial Anchoring System addresses the safety concerns
of physicians about subjecting patients to invasive surgical
interventions on the heart’s left ventricle. Made possible by the
Revivent system, the LIVE™ procedure can be performed as a separate
stand-alone procedure, concurrent with other procedures (e.g., CABG) or
during other occasions when a sternotomy is already employed. Neither a
myocardial incision nor cardiopulmonary bypass is required.
Additionally, the Revivent system is deployed using a straightforward,
epicardial approach that can be completed in about one hour.

About LIVE™: The World’s Only Reshaping, Restorative Left Ventricle
Therapy

Less Invasive Ventricular Enhancement™ (LIVE™) therapy is an innovative,
new off-pump (i.e., beating heart) procedure that helps restore the left
ventricle’s intrinsic functional efficiency, rather than relying on a
surrogate pumping device or other invasive treatment. The only therapy
currently designed to restore optimal left ventricle size and function,
LIVE provides physician teams with a gentler surgical option that
enables them to more confidently treat heart failure patients who may
not tolerate left ventricle incisions. LIVE fills the gap in available
heart failure treatments, offering the potential for more consistent and
favorable surgical outcomes, while giving heart failure patients and
their families renewed hope for a more productive life.

About BioVentrix

BioVentrix, a privately held medical technology company headquartered in
San Ramon, Calif., is focused on developing and commercializing
minimally invasive as well as nonsurgical therapies for treating heart
failure (HF).

NOTE: The Revivent™ Myocardial Anchoring System is not approved for sale
in the United States.